(288 days)
R95099
Not Found
No
The summary describes a diagnostic catheter for electrophysiology studies, focusing on its physical placement and function (recording electrograms and stimulation). There are no mentions of AI, ML, image processing, or performance metrics typically associated with AI/ML algorithms.
No.
The device is used for diagnostic purposes (electrogram recording and cardiac stimulation during diagnostic electrophysiology study), not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" states the device is used for "electrogram recording and cardiac stimulation during diagnostic electrophysiology study," indicating its role in diagnosis.
No
The device description clearly identifies the device as a "Cardiac Electrophysiology Diagnostic Catheter," which is a physical hardware device used for electrogram recording and cardiac stimulation. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "electrogram recording and cardiac stimulation during diagnostic electrophysiology study." This involves interacting directly with the patient's body (in vivo) to record electrical signals and stimulate the heart.
- Device Description: The device is described as a "Cardiac Electrophysiology Diagnostic Catheter," which is a device used within the body.
- Anatomical Site: The specified anatomical sites are within the patient's heart.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device operates in vivo (within the body).
N/A
Intended Use / Indications for Use
The device will be generally placed in the high right atrium, right ventricular apex, and His bundle, and in the coronary sinus of the cardiac anatomy, and be used for electrogram recording and cardiac stimulation during diagnostic electrophysiology study.
Product codes
74 DRF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
high right atrium, right ventricular apex, His bundle, coronary sinus of the cardiac anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
R95099
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2000
Jamil Mogul CEO/Chairperson Mogul Enterprises, Inc 6387 San Ignacio Avenue San Jose, CA 95119
K993698 Re: R95099
Slim Cath-Dx™ Cardiac Electrophysiology Diagnostic Catheter Regulatory Class: II (two) Product Code: 74 DRF Dated: May 17, 2000 Received: May 18, 2000
Dear Mr. Mogul:
We have reviewed your Section 510(k) notification of intent to market the we have referenced above and we have determined the device is aubstantially equivalent (for the indications for use stated in the Subblancearly ogazian marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Comments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You ene proviefore, market the device, subject to the general controls may) choro of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the
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Page 2 - Mr. Mogul
Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
proced to the manific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4346. Additionally, for questions on the promotion and (301) 331 1000 Also, please note the regulation entitled, "Misbranding (301) 594-4639. by reference to premarket notification" (21CFR 807.97). Other general by reference to promaibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Mark M. Melkersen
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Device and Radiological Health
Enclosure
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510(k) Number (if known): K993698
Device Name: Slim Cath-Dx™ Cardiac Electrophysiology Diagnostic Catheter
Indications For Use:
The device will be generally placed in the high right atrium, right ventricular apex, and His bundle, and in the coronary sinus of the cardiac anatomy, and be used for electrogram recording and cardiac stimulation during diagnostic electrophysiology study.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Manh n Melberm
Division of Cardiovascular & Respiratory Devices
510(k) Number K993698